Journal Articles

Journal Articles

Non-Animal Stabilised Hyaluronic Acid in the Treatment of Osteoarthritis of the Knee: A Tolerability Study

Clinical Drug InvestigationÅkermark C, Berg P, Bjorkman A, Malm P.

No safety concerns were raised in either the primary study or in the study extension. NASHA as an intra-articular therapy for OA of the knee appears to have an acceptable safety profile and thus merits further investigation regarding its long-term clinical efficacy.

The elimination kinetics of (131)I-labelled NASHA from the human knee joint were described by three distinct phases, with half-times of 1.5 hours, 1.5 days and 4 weeks. Most likely, the last value reflects the true half-life of NASHA following intra-articular injection since the labelling method used causes minimal modification of hyaluronan.

Intra-articular injection of non-animal stabilised hyaluronic acid (NASHA) for osteoarthritis of the hip: A pilot study

Clinical and Experimental RheumatologyBerg P, Olsson U.

The study results show that a single intra-articular injection of NASHA is a well tolerated and potentially effective therapy in the treatment of hip OA. Further studies of NASHA in this setting are warranted.

NASHA was not superior to placebo for the primary efficacy analysis. However, these data may be confounded by the inclusion of patients with OA at other sites, as significant benefits over placebo were found among patients with OA confined to the knee. Future trials of OA that examine a local therapy might need to consider restricting the study population to those patients having OA of only the signal joint.

The study concludes that a single injection of Durolane can reduce arthrosis associated knee pain sufficiently. The data are comparable with those published in clinical studies using other hyaluronic acids. The effects of Durolane are delayed but more sustained compared than those found for glucocorticoids. Because of the single injection, the authors saw an advantage in using Durolane compared to other conventional hyaluronic acids and glucocorticoids.

Safety, efficacy and predictive factors of efficacy of a single intra-articular injection of non-animal-stabilized-hyaluronic-acid in the hip joint: results of a standardized follow-up of patients treated for hip osteoarthritis in daily practice

Factors like a lower age of the patient and the involvement of a single joint influenced the referral of the patient to surgery. The administration of viscosupplementation, delayed the time until the patient was finally referred to surgery.

This study concludes that intra-articular HA is a useful intervention in patients with mild to moderate OA of the knee, can produce sustained pain relief at 6 months, and can reduce the requirement for analgesia and anti-inflammatory medication during this time.

Single-injection NASHA was well tolerated and, although there was no significant benefit versus saline control in the primary analysis, post-hoc analysis showed a statistically significant improvement in pain relief at 6 weeks among patients without clinical effusion at baseline.

This study shows that single-injection NASHA was well tolerated and non-inferior to MPA at 12 weeks. The benefit of NASHA was maintained to 26 weeks while that of MPA declined. An injection of NASHA at 26 weeks conferred long-term improvements without increased sensitivity or risk of complications.

Summary of Indications for UseDUROLANE (3mL): Symptomatic treatment of mild to moderate knee or hip osteoarthritis. In addition, DUROLANE has been approved in the EU for the symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, shoulder, elbow, wrist, fingers, and toes.

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